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510(k) K811263

TOX TM ANALYZER by Abbott Laboratories — Product Code JQZ

K811263 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TOX TM ANALYZER". The FDA issued a decision of Substantially Equivalent on May 29, 1981. The device falls under product code JQZ (Polarimeter), a Class I device regulated under 21 CFR 862.2050. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1981
Date Received
May 6, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polarimeter
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

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  • K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track (June 5, 2023)

FDA data resources